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Erector Spinae Plane Block With Ropivacaine for Major Upper Abdominal Surgery

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Phase 3
Locations
Kazakhstan
Study Type
Interventional
Intervention
Ropivacaine
Placebo
Sponsored by
Nazarbayev University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring ropivacaine, major upper abdominal surgery, supraumbilical, liver resection, colon resection, Whipple procedure, gastrectomy, anesthetics, local, erector spinae plane block

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults who are scheduled to undergo major upper abdominal surgery (e.g. Pancreato-duodenal resection). If enrollment rates are insufficient, patients undergoing other major upper abdominal surgery will be enrolled (e.g in the supraumbilical area: liver resection, colon resection; Whipple procedure; gastrectomy).
  2. Males or females 18-70 years of age
  3. American Society of Anesthesiologists physical status class I,II, III
  4. Signed informed consent

Exclusion Criteria:

  1. Patients undergoing emergency surgery
  2. Decompensated cardiovascular disease (e.g. left ventricular ejection fraction ≤40%), chronic heart failure, rhythm and conduction disorders, coagulopathies)
  3. Comorbid obesity (BMI≥35kg/m2)
  4. Anomalies of vertebral column
  5. Use of anticoagulants and patients with hypocoagulable conditions
  6. Pregnancy
  7. Physician preference for therapeutic anticoagulation
  8. Infection of skin at site of needle puncture
  9. Known allergies to study drugs

Sites / Locations

  • National Center for Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ropivacaine

Placebo

Arm Description

Ropivacaine 0.5% - 20 ml will be administered as erector spinae plane block under ultrasound guidance

No injection. Bandage will be placed over the presumed site of injection

Outcomes

Primary Outcome Measures

Mean cumulative opioid consumption up to 24 hours after surgery
Cumulative opioid consumption will be recorded for 24 hours following surgery

Secondary Outcome Measures

Post-operative pain score
Numerical rating scale (0= no pain; 10= worst pain imaginable) will be used
Time to ambulation
The time that the patient is able to walk independently, after surgery
Time to discharge
From time of surgery completion to discharge from hospital
Usage of NSAIDs post surgery
Dose

Full Information

First Posted
December 3, 2020
Last Updated
January 8, 2021
Sponsor
Nazarbayev University Medical Center
Collaborators
National Research Oncology and Transplantology Center, Kazakhstan
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1. Study Identification

Unique Protocol Identification Number
NCT04702685
Brief Title
Erector Spinae Plane Block With Ropivacaine for Major Upper Abdominal Surgery
Official Title
A Single Center, Randomized, Parallel Group Study to Evaluate the Efficacy of Ropivacaine Administered by Ultrasound-guided Erector Spinae Plane Block for Major Upper Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nazarbayev University Medical Center
Collaborators
National Research Oncology and Transplantology Center, Kazakhstan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Prospective, single-centre, randomized, controlled, open-label, evaluator-blinded, superiority trial.
Detailed Description
The primary objective is to establish whether ESP ropivacaine reduces post-operative opioid use and improves pain rating post-operatively. The secondary objectives include adverse event incidence, time to ambulation and time to discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
ropivacaine, major upper abdominal surgery, supraumbilical, liver resection, colon resection, Whipple procedure, gastrectomy, anesthetics, local, erector spinae plane block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Bandage with tape will be placed over the presumed site of anesthetic injection
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine
Arm Type
Experimental
Arm Description
Ropivacaine 0.5% - 20 ml will be administered as erector spinae plane block under ultrasound guidance
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
No injection. Bandage will be placed over the presumed site of injection
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
Local anesthetic for injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Bandage will be placed in the presumed injection site while patients in under general anesthesia
Primary Outcome Measure Information:
Title
Mean cumulative opioid consumption up to 24 hours after surgery
Description
Cumulative opioid consumption will be recorded for 24 hours following surgery
Time Frame
24 hours post-operation
Secondary Outcome Measure Information:
Title
Post-operative pain score
Description
Numerical rating scale (0= no pain; 10= worst pain imaginable) will be used
Time Frame
Measured post-operatively at 0, 2, 4, 6, 8, 10, 12, 16, 20, 24 hours after surgery.
Title
Time to ambulation
Description
The time that the patient is able to walk independently, after surgery
Time Frame
Between surgery and discharge from hospital, expected time is between 1 day to 1 week
Title
Time to discharge
Description
From time of surgery completion to discharge from hospital
Time Frame
Expected time to discharge is up to 2 weeks
Title
Usage of NSAIDs post surgery
Description
Dose
Time Frame
Total dose used during the 24 hour period after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults who are scheduled to undergo major upper abdominal surgery (e.g. Pancreato-duodenal resection). If enrollment rates are insufficient, patients undergoing other major upper abdominal surgery will be enrolled (e.g in the supraumbilical area: liver resection, colon resection; Whipple procedure; gastrectomy). Males or females 18-70 years of age American Society of Anesthesiologists physical status class I,II, III Signed informed consent Exclusion Criteria: Patients undergoing emergency surgery Decompensated cardiovascular disease (e.g. left ventricular ejection fraction ≤40%), chronic heart failure, rhythm and conduction disorders, coagulopathies) Comorbid obesity (BMI≥35kg/m2) Anomalies of vertebral column Use of anticoagulants and patients with hypocoagulable conditions Pregnancy Physician preference for therapeutic anticoagulation Infection of skin at site of needle puncture Known allergies to study drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitry Viderman, MD
Phone
+77055426716
Email
dmitry.viderman@nu.edu.kz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip la Fleur, RPh MSc
Organizational Affiliation
philip.lafleur@nu.edu.kz
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center for Oncology
City
Astana
Country
Kazakhstan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon request, we will share information with other researchers.
IPD Sharing Time Frame
Q3 and Q4 2021
IPD Sharing Access Criteria
Researchers on staff at an accredited university

Learn more about this trial

Erector Spinae Plane Block With Ropivacaine for Major Upper Abdominal Surgery

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